ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953

K061190 · Beckman Coulter, Inc. · CEW · Sep 15, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061190
• Device Name: ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
• Applicant: Beckman Coulter, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Sep 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions. The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.

Device Story

Access Intact PTH assay; paramagnetic particle, chemiluminescent immunoassay; quantitative determination of intact PTH in human serum/plasma. Input: patient serum/plasma samples. Principle: two-site immunoenzymatic sandwich assay; monoclonal anti-PTH antibody-alkaline phosphatase conjugate; paramagnetic particles coated with goat anti-PTH antibody. Process: incubation; magnetic separation of bound materials; addition of dioxetane-based chemiluminescent substrate (Lumi-Phos 530); luminometer measures light production proportional to PTH concentration. Output: quantitative PTH concentration (pg/mL). Used in clinical laboratories on Access Immunoassay Systems; operated by laboratory technicians. Results used by clinicians alongside clinical data for patient management decisions, including intraoperative monitoring.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A (total imprecision ≤8% CV routine, ≤12% CV intraoperative). Linearity/recovery studies (slope 1.00 ± 0.1). Analytical sensitivity (1 pg/mL routine, 6 pg/mL intraoperative). Interference testing per CLSI EP7-A (<10% bias). Method comparison (n=500 routine, n=400 intraoperative) showed high correlation (r ≥ 0.95) with predicates. Reference ranges established using 289 healthy subjects.

Technological Characteristics

Paramagnetic particle-based two-site immunoenzymatic (sandwich) assay. Detection via dioxetane-based chemiluminescence. Automated platform (Access Immunoassay Systems). Six-level synthetic PTH antigen calibrators. Reagent stability: 28 days. Calibration stability: 28 days.

Indications for Use

Indicated for quantitative measurement of intact PTH in human serum/plasma to aid differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy; can be used intraoperatively. No specific age/gender restrictions provided.

Regulatory Classification

Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Predicate Devices

• Roche Elecsys Parathyroid Hormone Test System (k992680)
• DPC Immulite Turbo PTH (k053533)

Submission Summary (Full Text)

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### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: k061190

### Submitter's Name and Address

Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 Telephone: [phone] Fax: [phone] Contact: Valynda Machen

Date Prepared: August 15, 2006

#### Device Names

| Proprietary Name: | Intact PTH and Intact PTH Calibrators on the Access® Immunoassay Systems |
|----------------------|--------------------------------------------------------------------------|
| Common Name: | Parathyroid Hormone Test |
| Classification Name: | Radioimmunoassay, Parathyroid Hormone |

#### Predicate Device(s)

Elecsys Parathyroid Hormone Test System Roche Diagnostics Corporation 9115 Hague Rd Indianapolis, IN 46250

510(k) Number: k992680

Immulite®/Immulite® 1000 Turbo Intact PTH Diagnostic Products Corporation Corporate Offices 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900

510(k) Number: k053533

# SEP 15 2006

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## Device Description

The Access Intact PTH reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, UniCel DxC600i, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the determination of intact parathyroid hormone (PTH) levels in human serum and plasma.

## Intended Use

The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

## Comparison of Technological Characteristics

| Attribute | Roche Elecsys Parathyroid<br>Hormone Test System | Immulite/Immulite 1000 Turbo<br>Intact PTH | Access Intact PTH |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Immunoassay for the in vitro<br>quantitative determination of intact<br>parathyroid hormone in human serum<br>and plasma for the differential<br>diagnosis of hypercalcemia and<br>hypocalcemia. | For in vitro diagnostic use with the<br>IMMULITE and IMMULITE 1000<br>Analyzers-for the quantitative<br>measurement of intact parathyroid<br>hormone (parathyrin, PTH) in EDTA<br>plasma or serum. It is intended as an<br>aid in the differential diagnosis of<br>hypercalcemia and hypocalcemia<br>and can be used intraoperatively. | The Access Intact PTH<br>assay is a paramagnetic<br>particle, chemiluminescent<br>immunoassay for the<br>quantitative determination<br>of intact parathyroid<br>hormone (parathyrin, PTH)<br>levels in human serum and<br>plasma using the Access<br>Immunoassay Systems. It<br>is indicated to aid in the<br>differential diagnosis of<br>hyperparathyroidism,<br>hypoparathyroidism, or<br>hypercalcemia of<br>malignancy and can be<br>used intraoperatively. |
| Assay<br>Principles | Electrochemiluminescence<br>immunoassay employing the<br>sandwich principle. | Solid phase, chemiluminescent<br>immunometric assay. | The Access Intact PTH<br>assay is a two-site<br>immunoenzymatic<br>("sandwich") assay. |
| Solid<br>Support | Streptavidin coated microparticles. | Bead coated with affinity purified goat<br>polyclonal anti-PTH (44-84) antibody. | Paramagnetic particles<br>coated with goat anti-PTH. |
| Detection<br>System | Chemiluminescent emission. | Chemiluminescent emission. | Utilizes dioxetane-based<br>chemiluminescent<br>substrate;<br>Measures light production<br>from a chemiluminescent<br>reaction. |
| Calibrator | 2 point calibration and master curve<br>provided via the reagent barcode. | Intact PTH Adjustors (Low and High)<br>of Iyophilized synthetic human intact<br>PTH in a buffered matrix. | Six levels (0, ~10, ~60,<br>~300, ~1500, and ~3500<br>pg/mL) of synthetic PTH<br>antigen in a buffered<br>protein solution with<br>preservatives. |

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# Summary of Analytical Studies

Imprecision: Imprecision was tested for concentrations from approximately 12 to 1400 pg/mL. Total imprecision ranged from 2.8% to 6.4% CV for the routine mode and 3.1% to 10.6% CV for the intraoperative mode.

Dilution Recovery (Linearity): Multiple dilutions of EDTA plasma samples were analyzed in the routine mode and intraoperative modes. Mean % recovery ranged from 91% to 103% for the routine mode and 85% to 98% for the intraoperative mode.

#### Methods Comparison:

A comparison of 500 values using the Access Intact PTH assay routine mode and a commercially available immunoassay system gave the following statistical data using Deming calculations: Range of observations=16-2627 pg/mL, Intercept=-11.5 pg/mL, Slope=1.09, Correlation coefficient (r)=0.99.

A comparison of 493 values using the Access Intact PTH assay routine mode and the intraoperative mode on the Access Immunoassay system gave the following statistical data using Deming calculations: Range of observations=13-2848 pg/mL, Intercept=9.69 pg/mL, Slope=0.94, Correlation coefficient (r)=1.00.

A comparison of 393 values using the Access Intact PTH intraoperative mode and a commercially available immunoassay system gave the following statistical data using Deming calculations: Range of observations=8-2453 pg/mL, Intercept=0.13 pg/mL, Slope=0.87, Correlation coefficient (r)=1.00.

Analytical Specificity: There was no significant interference from potential sample contaminants (bilirubin, hemoglobin, human serum albumin, and triglycerides) in either the routine or intraoperative modes.

Stability: Intact PTH reagents are stable for 28 days after opening. Intact PTH calibrators are singe use only. The calibration is stable for 28 days.

#### Summary of Clinical Studies

To establish a reference range, PTH concentrations were measured in 289 matched human EDTA plasma and serum samples from apparently healthy male and female subjects aged 19-67 years. Because of significant seasonal variations of 25-hydroxyvitamin D, the samples were collected during three time periods in two geographic latitudes. Additional testing was performed to exclude individuals with abnormal serum calcium, creatinine or 25-hydroxyvitamin D. A 95% non-parametric reference interval of 12-88 pg/mL was determined. Routine and intraoperative mode reference intervals are equivalent.

#### Conclusion

Intact PTH and Intact PTH Calibrators on the Access Immunoassay Systems is substantially equivalent to the Roche Elecsys Parathyroid Hormone Test System and the Immulite/Immulite 1000 Turbo Intact PTH assay for the quantitative determination of intact PTH levels in human serum and plasma.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Valynda Machen Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

SEP 1 5 2006

k061190 Re:

Trade/Device Name: Access Intact PTH Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW, JIT Dated: August 14, 2006 Received: August 16, 2006

Dear Ms. Machen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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# Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ______k061190

Device Name: Access Intact PTH Assay

Indications For Use:

The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of inumanououroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Access Intact PTH Calibrators are intended to calibrate the Access Intact PTH assay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K061190

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